NALPROPION PHARMACEUTICALS, INC. v. ACTAVIS LABORATORIES FL, INC.
- Aug 15 2019 |
- Category: CAFC Updates
Nalpropion holds a New Drug Application for and markets Contrave® for weight management in overweight or obese adults and asserted three patents against Actavis. Actavis appeals from the district court’s judgment that (1) its proposed naltrexone hydrochloride and bupropion hydrochloride extended-release tablets, which are the subject of an Abbreviated New Drug Application (“ANDA”), would infringe claim 1 of U.S. Patent 7,375,111, claims 26 and 31 of U.S. Patent 7,462,626, and claim 11 of U.S. Patent 8,916,195; (2) the asserted claims are not invalid; (3) the effective date of any FDA approval of the ANDA shall be no earlier than the latest expiration of the ’111, ’626, and ’195 patents; and (4) Actavis is permanently enjoined from manufacturing, using, or selling its ANDA product before the expiration of the patents in suit. While as a general matter written description may not be satisfied by so-called equivalent disclosure, in this case, buttressed by the district court’s fact-finding, and where the so-called equivalence relates only to resultant dissolution parameters rather than operative claim steps, the CAFC affirms the district court’s conclusion that the claims are valid, noting that rigidity should yield to flexible, sensible interpretation. The CAFC further concludes that claim 1 of the ’111 patent and claims 26 and 31 of the ’626 patent would have been obvious to a person of skill in the art in view of the prior art O’Malley and Jain references, and reverses the district court’s holding that these claims are not invalid. Chief Judge Prost dissents in part, disagreeing with the majority’s holding that a “substantially equivalent” disclosure may satisfy the written description requirement when the relevant claim limitation recites only “resultant dissolution parameters rather than operative claim steps” and indicating that he would find claim 11 of the ’195 patent invalid for lack of adequate written description.